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NCT06113796 Clinical Trial

Economic Analysis of Robotic Rectal Resection in German Health Care System

Rectal Cancer Clinical Trial

Official title:
Economic Analysis of Robotic Rectal Resection in German Health Care System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06113796
Other study ID # UKE Hamburg 3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2021

Study information
Verified date November 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the German diagnosis related groups (DRG) system.

Description:

Robotic surgery has many well-known benefits for patients and surgeons, while it comes with higher acquisition and maintenance costs. On the other hand, a higher proportion of minimally invasive procedures can save costs by reducing complications, decreasing hospital stays due to lower morbidity, and saving personnel. To what extent can robotic surgery be cost-covering or even profitable, depending on the postoperative course? This question is investigated under the conditions of the German DRG system.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date December 31, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18y - histologically proven rectal cancer with curative therapeutic approach - suitable for minimally-invasive surgery Exclusion Criteria: - no rectal cancer - primary open surgery

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Surgery
Robotic rectal resection, either sphincter preserving or extirpation

Locations
Country Name City State
Germany University of Hamburg Medical Institutions Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Costs of treatment costs caused by the case 1 year
Secondary Major Complication Clavin Dindo Score = 3 30 days postoperatively
Secondary Length of Hospital Stay Hospital Stay after Surgery 3 months
Secondary 30-days Readmission Readmission within 30 days after Surgery 30 days
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